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Eisai receives judicial review date for NICE Aricept rejection

Eisai has revealed that the British High Court has granted its request to fast track the date for the Judicial Review hearing challenging the process by which NICE reached its decision to ban anti-dementia medicines for NHS patients with newly diagnosed mild Alzheimer's disease

Japanese pharmaceutical company, Eisai, the licence holder of Alzheimerís disease treatment Aricept (donepezil) has revealed that the British High Court has granted its request to fast track the date for the Judicial Review hearing challenging the process by which the National Institute for Health and Clinical Excellence (NICE) reached its decision to ban anti-dementia medicines for NHS patients with newly diagnosed mild Alzheimer's disease.

Eisai is being supported in its review by the worldís largest pharmaceutical company, Pfizer, which is Eisaiís co-promotion partner for Aricept.

The High Court has listed the hearing to commence on 25 June 2007 and has allocated four days of court time.

Dr Paul Hooper, Managing Director of Eisai, said, ìIt is vital to have the Judicial Review heard as soon as possible, and we are delighted to now be one step closer to concluding this process. We believe that patients suffering from mild stages of Alzheimerís disease should be treated as soon as possible rather than having to wait until they have deteriorated further. Time lost before commencing treatment can never be regained."

PMLive reported in March 2007 that the High Court had granted permission to proceed to a Judicial Review on three grounds.

  • Procedural: since NICE has repeatedly refused to disclose a fully working version of the cost effectiveness model used to determine the value of treatment in patients with mild Alzheimer's disease, the process leading to the Final Appraisal Determination (FAD) and the new treatment guidance breached the principles of  procedural fairness

  • Irrationality: some of the assumptions made or conclusions drawn in the FAD are irrational or cannot be supported

  • Human Rights/Discrimination: the use of MMSE (Mini Mental State Examination) scores as a rigid tool to determine access to treatment discriminates against certain patient groups

NICE said at the time that it was disappointed Eisai had taken this step and considered their claim ìwithout foundationî and added that the inquiry would require it to divert energy and funding from the work it does to support patients and health professionals and get the most out of the resources available to the NHS.

The judicial review could see NICE facing significant change, if it were to lose. The future of the institute has already been questioned in the report from the Office of Fair Trading on 20 February, which suggested scrapping the Pharmaceutical Pricing Regulation Scheme (PPRS): a move that would pave the way for a new price setting body either to sit along side NICE or extend its current remit and powers.

2nd September 2008

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